The following data is part of a premarket notification filed by Shandong Zhushi Pharmaceutical Group Co., Ltd with the FDA for Disposable Sterile Syringe, With/without Needle;luer/luer-lock, Disposable Insulin Syringe, Disposable Hypodermic Needle.
| Device ID | K212033 |
| 510k Number | K212033 |
| Device Name: | Disposable Sterile Syringe, With/without Needle;luer/luer-lock, Disposable Insulin Syringe, Disposable Hypodermic Needle |
| Classification | Syringe, Piston |
| Applicant | Shandong Zhushi Pharmaceutical Group Co., Ltd No. 6, Shande Road, Shan County Heze, CN 274300 |
| Contact | Junhui Zhu |
| Correspondent | Bruce Cai Humiss Lnc. 5#501, No. 445, Renmin Road, Qingcun Town, Fengxian District Shanghai, CN 201414 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-29 |
| Decision Date | 2022-08-17 |